Sepsis is a systemic inflammatory response syndrome (SIRS) caused by an overwhelming immune response of the patient to invading microorganisms. When these microorganisms are lysed they release endotoxins in the blood, a condition called endotoxemia, which can lead to sepsis. Endotoxin released from the cell membranes of gram-negative organisms and cell wall fragments of gram-positive organisms is pathogenic. (Heumann D, et al. Curr Opin Microbiol 1998; 1:49-55.) The typical symptom of sepsis is a kind of hyperinflammatory state of the immune/inflammatory systems represented by elevated levels of pro-inflammatory mediators with development of multi-organ dysfunction syndrome and multi-organ failure (MOF). The body may develop this inflammatory response to microbes in the blood, urine, lungs, skin, or other tissues. (Levy M M, et al. Crit Care Med. 2003 April; 31(4):1250-1256.)
The initial infection can lead to an overwhelming reaction of the innate immune system with activation of proinflammatory cascades and appearance of various mediators, such as TNF-α, IL-1β and IL-6, resulting in SIRS and progressive MOF. The inflammatory cascade is mediated by cytokines, which are macrophage-derived, immunoregulatory peptides that target end-organ receptors in response to injury or infection. Cytokines can be categorized as either proinflammatory or antiinflammatory. Tumor necrosis factor-α, interleukin (IL)-1, and IL-6 are the most active proinflammatory cytokines released. (Matot I, et al. Intensive Care Med 2001; 27(suppl):3-9). At some point in sepsis, anti-inflammatory factors, such as IL-10, IL-1 receptor antagonist (IL-1RA), are released, perhaps representing a compensatory, anti-inflammatory response. Too much proinflammatory mediator release may trigger an uncontrolled, inflammatory response, resulting in consumptive depletion of the clotting system, and excessive release of anti-inflammatory mediators may contribute to immunosuppression or anergy, which occurs in humans with sepsis.
There is a need for effective treatments for inflammatory diseases and symptoms, including but not limited to sepsis, arthritis, inflammatory bowel diseases, multiple sclerosis and inflammation due to transplantation or viral infections.
Cordyceps sinensis (Berk.) Sacc., also known as Chinese caterpillar fungus and “Dong Chong Xia Cao,” is a black, blade-shaped fungus found primarily at high altitudes in the mountains of northwest and southwest China. The fungus is parasitic, growing on and deriving nutrients from the larvae of moths in the genera Hepialus and Thitarodes. Cordyceps sinensis spores infect Hepialus and Thitarodes caterpillars in late summer or early fall while the caterpillars are hibernating underground. The fungus then multiplies by yeast-like budding and grows in the form of threadlike hyphae, ultimately killing the host. During the following spring, the fruiting body (i.e., the sexual, teleomorphic form) of the fungus grows out of the caterpillar's head and emerges above ground. Recent molecular evidence has revealed that Hirstuella sinensis is the true anamorph of the asexual-phase species of Cordyceps sinensis. (Chen Y-Q. et al. Biochemical Systemics and Ecology. (2001) 29: 597-607.
Cordyceps sinensis has been reported to produce both immuno-stimulating and immunosuppressive effects. Thus, it appears that Cordyceps sinensis may be a bi-directional modulator of the immune system. For example, some studies reported that Cordyceps sinensis enhances the activities of macrophages and natural killer (NK) cells, while other studies reported that the fungus inhibits these activities under different circumstances. Cordyceps sinensis has been shown to suppress or enhance antibody production and the proliferation of T cells, thymocytes, and natural killer cells. Cordyceps sinensis has also been shown to suppress or enhance expression of IL1, IL2, IL6, IL10, CD4, CD5, CD8, CD25, tumor necrosis factor, interferons, etc. US Pat. App. Pub. No. 20030095982 discloses a pulmonary function-improving fraction from Cordyceps sinensis. US Pat. App. Pub. No. 20040001817 discloses anti-aging nutritional supplements comprising Cordyceps sinensis. 
Polysaccharides extracted from Cordyceps sinensis have been shown to alter apoptotic homeostasis, and to improve respiratory, renal and cardiovascular functions (Buenz et al., 2005, J Ethnopharmacol 96, 19-29; Zhu et al., 1998, J Altern Complement Med 4, 289-303; Zhu et al., 1998, J Altern Complement Med 4, 429-57), as well as to increase whole body sensitivity to insulin (Balon et al., 2002, J. Alternative Complementary Med 8, 315-23). However, the polysaccharide compositions of the extracts vary when the polysaccharides are extracted from different sources, from different strains, and under different growing conditions.